EBARIC 10 mg Orodispersible Tablet

Зміст інструкції

1. Ebaric 10 mg orodispersible tablets
   1. What is Ebaric and what is it used for
   2. What you need to know before you take Ebaric
   3. How to take Ebaric
   4. Possible side effects
   5. How to store Ebaric
   6. Contents of the pack and other information
2. Ebaric 20 mg orodispersible tablets
   1. What is Ebaric and what is it used for
   2. What you need to know before taking Ebaric
   3. How to take Ebaric
   4. Possible side effects
   5. How to store Ebaric
   6. Contents of the pack and other information

Ebaric 10 mg orodispersible tablets

Generic medicine.

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ebaric is and what it is used for
• 2. What you need to know before you take Ebaric
• 3. How to take Ebaric
• 4. Possible side effects
• 5. How to store Ebaric
• 6. Contents of the pack and other information

1. What is Ebaric and what is it used for

Ebaric is a medicine that relieves the symptoms of allergic reactions (antihistamine/antihistaminic).
Ebaric is used:

• for the treatment of symptoms of seasonal and perennial allergic rhinitis, with or without allergic conjunctivitis.
• to alleviate itching and the formation of wheals in urticaria of unknown origin (urticaria).

2. What you need to know before you take Ebaric

Do not take Ebaric

• if you are allergic to ebastine, menthol (a component of peppermint aroma) or any of the other ingredients of this medicine (listed in section 6)
• Ebaric should not be used for the treatment of urticaria in adolescents under 18 years of age, as experience in this patient group is limited or there is no experience in children under 12 years of age, respectively.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ebaric:
Caution is necessary when taking ebastine:

• if you have low levels of potassium in your blood
• in case of certain changes in the ECG (known prolongation of the QTc interval on the ECG), which can occur in some forms of heart disease
• if you are taking certain antibiotics (macrolide antibiotics such as erythromycin) or medicines used to treat fungal infections (antifungals such as ketoconazole or itraconazole) or tuberculosis (e.g. rifampicin) at the same time
• if you suffer from severe impairment of liver function (hepatic insufficiency).

In some patients, long-term treatment with ebastine may increase the risk of dental caries due to dry mouth. Therefore, oral hygiene is particularly important.

Other medicines and Ebaric
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
The concomitant administration of ebastine (the active ingredient of Ebaric) and certain antibiotics (for
example, erythromycin) or medicines used to treat fungal infections (for example, ketoconazole or
itraconazole) may lead to an increase in the levels of ebastine in the blood. Compared to the
administration of ketoconazole or erythromycin alone, this can lead to more pronounced changes
in the ECG (increase in the known prolongation of the QTc interval by approximately 10 msec.)
The concomitant administration of ebastine with rifampicin (active ingredient for treating
tuberculosis) may lead to lower levels of ebastine in the blood and therefore reduce its effects.
No interactions have been observed between ebastine and

• Theophylline (a substance for the treatment of asthma),
• Warfarin (anticoagulant),
• Cimetidine (a substance for the treatment of gastric ulcer),
• Diazepam (a substance for the treatment of anxiety and tension) or
• Alcohol.

Ebaric with food and drink
When Ebaric is taken with food, the concentration in the blood of the active metabolite
of ebastine (carebastine) increases. However, clinical efficacy is not affected.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
To date, there is no experience of safety in humans for the fetus. For this reason, you must
take Ebaric during pregnancy only if your doctor believes that the expected benefit outweighs the
possible risk.
Breastfeeding
You should not take Ebaric if you are breastfeeding as it is not known whether the active ingredient passes into
breast milk.

Driving and using machines
Most patients treated with Ebaric can drive or perform other activities that require
good reaction ability. However, to identify sensitive subjects with abnormal reactions to
Ebaric, you must check your individual reaction before driving or performing complex activities. You may feel drowsy or dizzy. Please also read section 4.
"Possible side effects"

Important information about some ingredients of Ebaric
Ebaric 10 mg tablets contains 0.53 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine which may be harmful in case of phenylketonuria (PKU), a
rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it
correctly.
Ebaric contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per dispersible tablet, i.e.
essentially ‘sodium-free’.

3. How to take Ebaric

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Unless otherwise prescribed by your doctor, the normal dose for adults and children of at least 12 years is:

IndicationAgeDose
Allergic rhinitis
In case of severe symptoms
Children aged 12 years and
over and adults
1 orodispersible tablet
(equivalent to 10 mg of
ebastine) once a
day
2 orodispersible tablets
(equivalent to 20 mg of
ebastine) once a
day
Perennial allergic rhinitis Children aged 12 years and
over and adults
1-2 orodispersible tablets
(equivalent to 10 - 20 mg of ebastine)
once a day
Urticaria
In case of severe symptoms
Adults over 18 years of
age
1 orodispersible tablet
(equivalent to 10 mg of
ebastine) once a
day
2 orodispersible tablets
(equivalent to 20 mg of
ebastine) once a
day
Patients with impaired liver function
No dose adjustment is required in patients with mild to
moderate hepatic insufficiency.
In patients with severe hepatic insufficiency, the dose of ebastine should not exceed 10 mg.
Patients with impaired renal function
In patients with impaired renal function, no dose adjustment is necessary
for treatment periods of up to 5 days.

Method of administration
Ebaric can be taken during meals or independently of meal times.
Remove the medicine from the blister immediately before use. Carefully push the
orodispersible tablet out of the blister with dry hands and place the tablet on the tongue. The
orodispersible tablet will dissolve directly in the mouth and can be swallowed easily. No
water or other liquids are needed to take this medicine.

Duration of treatment
The doctor will determine the duration of therapy.
Contact your doctor if you feel that the effects of Ebaric are too strong or too weak.

If you take more Ebaric than you should
There is no specific antidote for the active ingredient ebastine.
If you suspect an overdose with Ebaric, inform your doctor. Depending on the severity
of the intoxication, the doctor will take appropriate measures (monitoring of vital functions,
including monitoring via ECG with assessment of the QT interval for at least 24 hours,
symptomatic treatment and gastric lavage), if necessary.

If you forget to take Ebaric
Do not take a double dose to make up for a missed dose. Continue treatment as
usual.

If you stop taking Ebaric
If you stop or prematurely terminate treatment, the typical symptoms of the disorder are likely to
recur soon.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects
The following side effects have been reported very commonly (may affect more than 1 in 10 people):

• Headache

The following side effects have been reported commonly (may affect up to 1 in 10 people):

• Dry mouth
• Drowsiness

The following side effects have been reported rarely (may affect up to 1 in 1000 people):

• Allergic reactions (such as anaphylaxis (severe allergic reaction, life-threatening requiring immediate medical attention) and swelling, for example of the throat, lips or hands (angioedema))
• General nervousness, Insomnia
• Dizziness, reduced sensitivity to touch or sensation, altered sense of taste
• Palpitations, fast heartbeat
• Abdominal pain, vomiting, nausea, dyspepsia
• Liver disorders, cholestasis, elevated liver parameters in the blood (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin)
• Urticaria, skin rash, skin inflammation
• Menstrual disorders
• Edema (swelling of the tissues), fatigue

Frequency not known (the frequency cannot be estimated from the available data)

• increased weight
• increased appetite

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ebaric

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package/blister after
“EXP”. The expiry date refers to the last day of that month.

Storage precautions
Store the medicine in the original package to protect it from light.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ebaric contains

• The active ingredient is: ebastine 1 orodispersible tablet contains 10 mg of ebastine.
• The other ingredients are: Mannitol (Ph. Eur.), corn starch, anhydrous colloidal silica, sodium stearyl fumarate (Ph. Eur.), aspartame (E 951), peppermint aroma

Description of the appearance of Ebaric and contents of the pack
Ebaric orodispersible tablets are white and round.
Blisters in aluminium-PVC/ PVDC
Available in packs of 10, 20, 30, 50 and 100 orodispersible tablets.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Str. 8 - 10
13435 Berlin, Germany

Manufacturer
Laboratorios Medicamentos Internacionales, S.A.
C/Solana, 26, Torrejón de Ardoz, 28850 Madrid
Spain

Sales representative
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Ebastin Aristo
Germany: Ebastin Aristo 10 mg melt tablets
Italy: Ebaric
Spain: Ebastine Aristo 10 mg orodispersible tablet EFG

Ebaric 20 mg orodispersible tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ebaric is and what it is used for
• 2. What you need to know before you take Ebaric
• 3. How to take Ebaric
• 4. Possible side effects
• 5. How to store Ebaric
• 6. Contents of the pack and other information

1. What is Ebaric and what is it used for

Ebaric is a medicine that relieves the symptoms of allergic reactions (antihistamine/antihistaminic).
Ebaric is used:

• for the treatment of symptoms of seasonal and perennial allergic rhinitis, with or without allergic conjunctivitis.
• to alleviate itching and the formation of wheals in urticaria of unknown origin (urticaria).

2. What you need to know before taking Ebaric

Do not take Ebaric

• if you are allergic to ebastine, menthol (a component of peppermint aroma) or any of the other ingredients of this medicine (listed in section 6).
• EbaricEbaric should not be used for the treatment of urticaria in adolescents under 18 years of age, as experience in this patient group is limited or there is no experience in children under 12 years of age, respectively.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ebaric:
Caution is necessary when taking ebastine

• if you have low levels of potassium in your blood
• in case of certain changes in the ECG (known prolongation of the QT interval on the ECG), which can occur in some forms of heart disease
• if you are taking certain antibiotics (macrolide antibiotics such as erythromycin) or medicines used to treat fungal infections (antifungals such as ketoconazole or itraconazole) or tuberculosis (e.g. rifampicin) at the same time
• if you suffer from severe impairment of liver function (hepatic insufficiency).

In some patients, long-term treatment with ebastine may increase the risk of dental caries due to dry mouth. Therefore, oral hygiene is particularly important.

Other medicines and Ebaric
Tell your doctor or pharmacist if you are taking, have recently taken or could take any other medicines.
The concomitant administration of ebastine (the active ingredient of Ebaric) and certain antibiotics (e.g. erythromycin) or medicines used to treat fungal infections (e.g. ketoconazole or itraconazole) may lead to an increase in ebastine levels in the blood. Compared to the administration of ketoconazole or erythromycin alone, this may lead to more pronounced changes in the ECG (increase in the known prolongation of the QT interval by approximately 10 msec).
The concomitant administration of ebastine with rifampicin (active ingredient for treating tuberculosis) may lead to lower ebastine levels in the blood and therefore reduce its effects.
No interactions have been observed between ebastine and

• Theophylline (a substance for the treatment of asthma),
• Warfarin (anticoagulant),
• Cimetidine (a substance for the treatment of gastric ulcer),
• Diazepam (a substance for the treatment of anxiety and tension) or
• Alcohol.

Ebaric with food and drink
When Ebaric is taken with food, the concentration of the active metabolite of ebastine (carebastine) in the blood increases. However, clinical efficacy is not affected.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
To date, there is no safety experience in humans for the fetus. For this reason, you should only take Ebaric during pregnancy if your doctor believes that the expected benefit outweighs the possible risk.
Breastfeeding
You should not take Ebaric if you are breastfeeding, as it is not known whether the active ingredient passes into breast milk.

Driving and using machines
Most patients treated with Ebaric can drive or perform other activities that require good reaction ability. However, to identify sensitive individuals with abnormal reactions to Ebaric, you should check your own reaction before driving or performing complex activities. You may experience drowsiness or dizziness. Please also read section 4 "Possible side effects".

Important information about some ingredients of Ebaric
Ebaric 20 mg tablets contains 1.06 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.
Ebaric contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dispersible tablet, i.e. essentially ‘sodium-free’.

3. How to take Ebaric

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Unless otherwise prescribed by your doctor, the normal dose for adults and children of at least 12 years is:

IndicationAgeDose
Allergic rhinitis
In case of severe symptoms
Children aged 12 years and
over and adults
10 mg of ebastine once
daily*
20 mg of ebastine once
daily
Perennial allergic rhinitis Children aged 12 years and
over and adults

• 10 - 20 mg of ebastine once daily

Urticaria
In case of severe symptoms
Adults over 18 years of
age
10 mg of ebastine once
daily*
20 mg of ebastine once
daily
* For this dosage, Ebaric 10 mg is available.
Patients with impaired liver function
No dose adjustment is required in patients with mild to
moderate hepatic insufficiency. In patients with severe hepatic insufficiency, the dose of ebastine should not exceed 10 mg.
Patients with impaired renal function
In patients with impaired renal function, no dose adjustment is necessary
for treatment periods of up to 5 days.

Method of administration
Ebaric can be taken during meals or independently of meal times.
Remove the medicine from the blister immediately before use. Carefully push the
orodispersible tablet out of the blister with dry hands and place the tablet on the tongue. The
orodispersible tablet will dissolve directly in the mouth and can be swallowed easily. No
water or other liquids are needed to take this medicine.

Duration of treatment
The doctor will determine the duration of therapy.
Contact your doctor if you feel that the effects of Ebaric are too strong or too weak.

If you take more Ebaric than you should
There is no specific antidote for the active ingredient ebastine.
If you suspect an overdose with Ebaric, inform your doctor. Depending on the severity
of the intoxication, the doctor will take appropriate measures (monitoring of vital functions,
including monitoring via ECG with assessment of the QT interval for at least 24 hours,
symptomatic treatment and gastric lavage), if necessary.

If you forget to take Ebaric
Do not take a double dose to make up for a missed dose. Continue treatment as
usual.

If you stop taking Ebaric
If you stop or prematurely terminate treatment, the typical symptoms of the disorder are likely to
recur soon.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects
The following side effects have been reported very commonly (may affect more than 1
in 10 people):
:

• Headache,

The following side effects have been reported commonly (may affect up to 1 in
10 people):
:

• Dry mouth
• Drowsiness

The following side effects have been reported rarely (may affect up to 1 in

• 1,000):
• Allergic reactions (such as anaphylaxis (severe allergic reaction, life-threatening requiring immediate medical treatment) and swelling for example of the throat, lips or hands (angioedema))
• General nervousness, Insomnia
• Dizziness, reduced sensitivity to touch or sensation, altered sense of taste
• Palpitations, Rapid pulse
• Abdominal pain, vomiting, nausea, dyspepsia
• Liver disorders, cholestasis, elevated liver parameters in the blood (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin)
• Urticaria, skin rash, skin inflammation
• Menstrual disorders
• Edema (swelling of tissues), fatigue

Frequency not known (the frequency cannot be estimated from the available data)

• Weight gain
• Increased appetite

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine

5. How to store Ebaric

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package/blister after
“EXP”. The expiry date refers to the last day of that month.

Storage precautions
Keep the medicine in the original package to protect it from light.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ebaric contains
The active ingredient is: ebastine
1 orodispersible tablet contains 20 mg of ebastine.
The other ingredients are:
mannitol (Ph. Eur.), corn starch, anhydrous colloidal silica, sodium stearyl fumarate (Ph. Eur.)
aspartame (E 951), peppermint flavour

Description of the appearance of Ebaric and contents of the pack
Ebaric orodispersible tablets are white and round.
Aluminum-PVC/ PVDC blisters
Available in packs of 10, 20, 30, 50 and 100 orodispersible tablets.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Str. 8 - 10
13435 Berlin, Germany

Manufacturer
Laboratorios Medicamentos Internacionales, S.A.
C/Solana, 26, Torrejón de Ardoz, 28850 Madrid
Spain

Marketing Authorisation Distributor
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Ebastin Aristo
Germany: Ebastin Aristo 20 mg Schmelztabletten
Italy: Ebaric
Spain: Ebastine Aristo 20 mg bucodispersable tablet EFG